Drug Information

Product NDC: 0002-8233

Proprietary Name: Insulin Lispro Protamine and Insulin Lispro Injectable Suspension

Non Proprietary Name: Insulin lispro

Active Ingredient(s):
  • 100 [iU]/mL INSULIN LISPRO

Administration Route(s): SUBCUTANEOUS


Pharmacy Class(es):
  • Insulin Analog [EPC];
  • Insulin [Chemical/Ingredient]

Labeler Information

Labeler Name: Eli Lilly and Company
FDA Application Number: BLA021017
Marketing Category: BLA
Start Marketing Date:2/12/2020

Package Information

No. Package Code Package Description Billing Unit
10002-8233-055 SYRINGE in 1 CARTON (0002-8233-05) / 3 mL in 1 SYRINGE (0002-8233-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0002-8233The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEInsulin Lispro Protamine and Insulin Lispro Injectable SuspensionThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXMix75/25 KwikPenA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEInsulin lisproThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/12/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA021017This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEEli Lilly and CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEINSULIN LISPROAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESInsulin Analog [EPC], Insulin [Chemical/Ingredient] 

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This page was last updated on: 2/1/2023